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transducer-monitor interfacing
Millar Instruments
Summary: The transducer-monitor interfacing device by Millar Instruments is used for ablation procedures in tumor treatment. Key evidence highlights its role in improving sensor-tissue interfaces.
FDA Clearance Information
Pathway
510K
Number
K842150 ↗
Decision Date
October 26, 1984
Product Code
DXO
Device Class
Class 2
Evidence
0 studies
The transducer-monitor interfacing device was cleared by the FDA via the 510(k) pathway on October 26, 1984. It is manufactured by Millar Instruments and classified as a Class 2 device.
What It Is
The transducer-monitor interfacing device is designed to facilitate the connection between transducers and monitoring systems, primarily used in ablation procedures for tumor treatment. It ensures accurate signal transmission and data acquisition.
Clinical Applications
This device is commonly used in clinical settings for tumor ablation procedures, where precise monitoring and data collection are critical. It aids in the effective treatment of tumors by ensuring reliable interfacing between diagnostic and therapeutic equipment.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and reviews, published up to 2024. These studies explore the device's applications and advancements in interfacing technology.
Reported Outcomes
Published studies report advancements in neural and mucosa-interfacing technologies, highlighting the potential for improved sensor-tissue interfaces. The device is noted for its role in enhancing data accuracy and reliability in clinical settings.
Safety Profile
Reported complications include challenges in establishing robust sensor-tissue interfaces and issues with device localization and retention. These factors are critical for ensuring long-term biosensing efficacy.
Evidence Limitations
The evidence highlights gaps in long-term efficacy data and the need for further research on device retention and power transfer. More comprehensive studies are required to fully understand the device's impact on clinical outcomes.
Frequently Asked Questions
What are the clinical indications for transducer-monitor interfacing?
The device is indicated for use in tumor ablation procedures, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report improvements in sensor-tissue interfacing and data accuracy, crucial for effective tumor treatment.
What complications have been reported?
Safety data indicate challenges with sensor-tissue interface robustness and device retention, impacting long-term use.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.